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      • Record: found
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      Effect of lateral wedge-shaped orthopedic insole on patients with genu varus: A protocol for systematic review and meta-analysis

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          Abstract

          Background

          Genu varus (GV) is a common deformity characterized by leg bending, which seriously threatens human health. At present, there is no definite conclusion to explain the cause of genu varus. The purpose of this study is to systematically review and meta-analysis the effectiveness and scientific basis of the clinical efficacy of customized orthopedic insoles on genu varus and hope to provide a reference for future research in this field.

          Methods

          The following electronic databases will be searched from inception to January 2022: Pubmed, Cochrane Library, MEDLINE, EMBASE, Web of Science, Weipu, Wanfang Data, and CNKI. Randomized controlled trials (RCTs) were collected to examine the effect of lateral wedge-shaped orthopedic insole on patients with genu varus. We will consider inclusion, select high-quality articles for data extraction and analysis, and summarize the intervention effect of lateral wedge orthotic insoles on patients with genu varus. Two reviewers will screen titles, abstracts, and full texts independently according to inclusion criteria; Data extraction and risk of bias assessment were performed in the included studies. We will use a hierarchy of recommended assessment, development, and assessment methods to assess the overall certainty of the evidence and report findings accordingly. Endnote X8 will be applied in selecting the study, Review Manager 5.3 will be applied in analyzing and synthesizing.

          Results

          The results will provide evidence for judging the effect of lateral wedge-shaped orthopedic insole on patients with genu varus.

          Conclusion

          Our study will provide reliable evidence for the effect of lateral wedge-shaped orthopedic insole on patients with genu varus.

          Trail registration

          INPLASY registration number: INPLASY202190002 https://www.google.com/search?client=firefox-b-d&q=INPLASY202190002.

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          Most cited references22

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          The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials

          Julian P. T. Higgins, Douglas G. Altman, Peter C. Gøtzsche … (2014)
          Flaws in the design, conduct, analysis, and reporting of randomised trials can cause the effect of an intervention to be underestimated or overestimated. The Cochrane Collaboration’s tool for assessing risk of bias aims to make the process clearer and more accurate
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            American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee.

            Marc Hochberg, Roy D Altman, Karine Toupin April … (2012)
            To update the American College of Rheumatology (ACR) 2000 recommendations for hip and knee osteoarthritis (OA) and develop new recommendations for hand OA. A list of pharmacologic and nonpharmacologic modalities commonly used to manage knee, hip, and hand OA as well as clinical scenarios representing patients with symptomatic hand, hip, and knee OA were generated. Systematic evidence-based literature reviews were conducted by a working group at the Institute of Population Health, University of Ottawa, and updated by ACR staff to include additions to bibliographic databases through December 31, 2010. The Grading of Recommendations Assessment, Development and Evaluation approach, a formal process to rate scientific evidence and to develop recommendations that are as evidence based as possible, was used by a Technical Expert Panel comprised of various stakeholders to formulate the recommendations for the use of nonpharmacologic and pharmacologic modalities for OA of the hand, hip, and knee. Both “strong” and “conditional” recommendations were made for OA management. Modalities conditionally recommended for the management of hand OA include instruction in joint protection techniques, provision of assistive devices, use of thermal modalities and trapeziometacarpal joint splints, and use of oral and topical nonsteroidal antiinflammatory drugs (NSAIDs), tramadol, and topical capsaicin. Nonpharmacologic modalities strongly recommended for the management of knee OA were aerobic, aquatic, and/or resistance exercises as well as weight loss for overweight patients. Nonpharmacologic modalities conditionally recommended for knee OA included medial wedge insoles for valgus knee OA, subtalar strapped lateral insoles for varus knee OA, medially directed patellar taping, manual therapy, walking aids, thermal agents, tai chi, self management programs, and psychosocial interventions. Pharmacologic modalities conditionally recommended for the initial management of patients with knee OA included acetaminophen, oral and topical NSAIDs, tramadol, and intraarticular corticosteroid injections; intraarticular hyaluronate injections, duloxetine, and opioids were conditionally recommended in patients who had an inadequate response to initial therapy. Opioid analgesics were strongly recommended in patients who were either not willing to undergo or had contraindications for total joint arthroplasty after having failed medical therapy. Recommendations for hip OA were similar to those for the management of knee OA. These recommendations are based on the consensus judgment of clinical experts from a wide range of disciplines, informed by available evidence, balancing the benefits and harms of both nonpharmacologic and pharmacologic modalities, and incorporating their preferences and values. It is hoped that these recommendations will be utilized by health care providers involved in the management of patients with OA. Copyright © 2012 by the American College of Rheumatology.
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              Lateral wedge insoles for medial knee osteoarthritis: 12 month randomised controlled trial

              Kim Bennell, Kelly-Ann Bowles, Craig Payne … (2011)
              Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis. Design Randomised controlled trial. Setting Community in Melbourne, Australia. Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis. Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months. Main outcome measures Primary symptomatic outcome was change in overall knee pain (past week) measured on an 11 point numerical rating scale. Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans. Secondary clinical outcomes included changes in measures of pain, function, stiffness, and health related quality of life. Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions. Results Between group differences did not differ significantly for the primary outcomes of change in overall pain (−0.3 points, 95% confidence intervals −1.0 to 0.3) and change in medial tibial cartilage volume (−0.4 mm3, 95% confidence interval −15.4 to 14.6), and confidence intervals did not include minimal clinically important differences. None of the changes in secondary outcomes showed differences between groups. Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles. Trial registration Australian New Zealand Clinical Trials Registry ACTR12605000503628 and ClinicalTrials.gov NCT00415259.
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                Author and article information

                Contributors
                Zhongyi Deng: Role: ConceptualizationRole: Data curationRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Xinwei Yang: Role: ConceptualizationRole: ResourcesRole: Writing – review & editing
                Xiaochuan Li: Role: Conceptualization
                Xiali Xue: Role: Data curationRole: ResourcesRole: Validation
                Huiqiang Luo: Role: Formal analysisRole: Project administration
                Gaitian Wu: Role: Investigation
                Luyuan Zeng: Role: Data curation
                Yun Qi: Role: Formal analysis
                Ning Li:
                ORCID: https://orcid.org/0000-0002-0394-933X
                Role: Funding acquisitionRole: SupervisionRole: Writing – review & editing
                Fatih Özden: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS One
                Journal ID (publisher-id): plos
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 16 September 2022
                Publication date Collection: 2022
                Volume: 17
                Issue: 9
                Electronic Location Identifier: e0274789
                Affiliations
                [1 ] Institute of Sports Medicine and Health, Chengdu Sport University, Chengdu, Sichuan, PR China
                [2 ] The Third Affiliated Hospital of SUN YAT-SEN University, Guangzhou, Guangdong, PR China
                [3 ] Nanchong Gaoping Traditional Chinese Medicine Hospital, Nanchong, Sichuan, PR China
                [4 ] School of Sports Medicine and Health, Chengdu Sport University, Chengdu, Sichuan, PR China
                [5 ] The Third People Hospital of Chengdu, Chengdu, Sichuan, PR China
                Mugla Sitki Kocman Universitesi, TURKEY
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0000-0002-0394-933X
                Article
                Publisher ID: PONE-D-22-05089
                DOI: 10.1371/journal.pone.0274789
                PMC ID: 9481019
                PubMed ID: 36112602
                SO-VID: affb3e7f-d37f-4675-93b1-b1fcc7e0d682
                Copyright © © 2022 Deng et al
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 19 February 2022
                Date accepted : 19 August 2022
                Page count
                Figures: 1, Tables: 1, Pages: 9
                Funding
                Funded by: Key Laboratory of Sports Medicine of Sichuan Province, Institute of Sports Medicine and Health, Chengdu Sport University
                Award ID: 2022-A002
                Award Recipient :
                ORCID: https://orcid.org/0000-0002-0394-933X
                This work is supported by the Key Laboratory of Sports Medicine of Sichuan Province, Institute of Sports Medicine and Health, Chengdu Sport University (grant Number: 2022-A002).Thanks to the support of this organization, we have the conditions to sort out and modify this article, and the organization also provides the fee for submission, so that we can concentrate on reading and analyzing the literature.
                Categories
                Subject: Study Protocol
                Subject: Biology and Life Sciences
                Subject: Bioengineering
                Subject: Biotechnology
                Subject: Medical Devices and Equipment
                Subject: Orthotics
                Subject: Engineering and Technology
                Subject: Bioengineering
                Subject: Biotechnology
                Subject: Medical Devices and Equipment
                Subject: Orthotics
                Subject: Medicine and Health Sciences
                Subject: Medical Devices and Equipment
                Subject: Orthotics
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Feet
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Feet
                Subject: Research and Analysis Methods
                Subject: Mathematical and Statistical Techniques
                Subject: Statistical Methods
                Subject: Metaanalysis
                Subject: Physical Sciences
                Subject: Mathematics
                Subject: Statistics
                Subject: Statistical Methods
                Subject: Metaanalysis
                Subject: Research and Analysis Methods
                Subject: Research Assessment
                Subject: Systematic Reviews
                Subject: Medicine and Health Sciences
                Subject: Clinical Medicine
                Subject: Clinical Trials
                Subject: Randomized Controlled Trials
                Subject: Medicine and Health Sciences
                Subject: Pharmacology
                Subject: Drug Research and Development
                Subject: Clinical Trials
                Subject: Randomized Controlled Trials
                Subject: Research and Analysis Methods
                Subject: Clinical Trials
                Subject: Randomized Controlled Trials
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Legs
                Subject: Research and Analysis Methods
                Subject: Database and Informatics Methods
                Subject: Database Searching
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Body Limbs
                Custom metadata
                Data Availability This protocol reports no data produced or analyzed.

                ScienceOpen disciplines: Uncategorized
                Data availability:
                ScienceOpen disciplines: Uncategorized

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